Nitron CryoConsole™Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000593902), received between Jul 8, 2025 and Jul 24, 2025 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (P020045); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AN ERROR MESSAGE WAS RECEIVED STATING THAT THE SYSTEM DETECTED AN UNEXPECTED TEMPERATURE DURING SYSTEM FLUSH. AN ERROR MESSAGE WAS ALSO RECEIVED STATING THAT THE SYSTEM DETECTED A HIGHER-THAN-EXPECTED FLOW RATE INDICATING A TREATMENT OVERFLOW. FIELD SERVICE ARRIVED TO PERFORM TROUBLESHOOTING AND RESOLVE THE ERROR. THE CASE WAS ABORTED UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589607 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO CASE, AN ERROR MESSAGE WAS RECEIVED STATING THAT THE SYSTEM DETECTED A HIGHER THAN EXPECTED FLOW RATE INDICATING A TREATMENT OVERFLOW. THE DIRECTION OF THE COAXIAL UMBILICAL WAS SWAPPED, THE COAXIAL UMBILICAL AND CATHETER WERE REPLACED, AND THE CONSOLE WAS REBOOTED WITHOUT RESOLUTION. TEST ABLATIONS ON THE CONSOLE RESULTED IN CONTINUED N-001 SYSTEM NOTICES. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434240 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020045. One submission often covers many models, so check the product and lot details in each record.

• Z-2777-2015 · Sep 1, 2015 · Terminated
  Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
• Z-1452-06 · Aug 4, 2006 · Terminated
  7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.